FMD vaccine receives conditional approval

GAITHERSBURG, Md. – The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) issued a conditional license for GenVec, Inc.’s foot-and-mouth disease vaccine for use in cattle, the company announced June 7.

Antelope Valley Bios, Inc. received the conditional license and is manufacturing the vaccine under contract from GenVec. GenVec developed and tested the vaccine under contract with the US Department of Homeland Security’s Science and Technology Directorate, according to the company. GenVec’s vaccine is the first licensed by the USDA Center for Veterinary Biologics, the company said.

"This conditional approval is a significant event as it represents GenVec's first approved product," said Bryan T. Butman, Ph.D., senior vice President of Vector Operations and the head of GenVec's FMD program. "This achievement demonstrates GenVec's ability to bring its technology through the regulatory review process and validates the utility of our core technology to make effective genetic vaccines."

Under the conditional license, Federal emergency management officials within USDA can distribute the vaccine should the need arise. APHIS issues conditional licenses in the event of an emergency situation, limited market or other special circumstance. In GenVec's case, the special circumstance was the need for an FMD vaccine that was capable of being manufactured in the US that allowed for the differentiation between infected and vaccinated animals. The vaccine will now be available in the event of an FMD emergency situation, GenVec said.

GenVec also announced that Merial, the animal health division of Sanofi, has the rights to develop and commercialize GenVec's FMD vaccine for use in cattle.